RecruitingPhase 3NCT05904119

Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

411 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

First Progression of Glioblastoma

Summary

Despite comprehensive multimodal treatment of newly diagnosed glioblastoma, almost all patients suffer from tumour relapse. Currently, no standard of care exists to treat these tumour relapses. Treatment options include repeated surgery (if feasible), systemic therapy (bevacizumab, lomustine, temozolomide re-challenge), reirradiation and best supportive care. Currently, the superiority of combined chemoradiation versus chemotherapy alone remains unproven. Given that lomustine is the standard chemotherapeutic agent for the treatment of recurrent glioblastoma in Europe and the unclear efficacy of reirradiation, we want to explore whether combining lomustine and reirradiation may be a better treatment than lomustine alone. The results of the prospective randomized trial proposed here should demonstrate a significant improvement in overall survival when lomustine is combined with reirradiation in patients with recurrent glioblastoma compared to lomustine alone without adversely affecting quality of survival. The trial will be stopped based on overall survival in a preplanned futility and efficacy interim analysis.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is for people whose glioblastoma (an aggressive brain tumor) has come back after initial treatment. It is testing whether adding re-irradiation (targeted radiation therapy) to a chemotherapy drug called lomustine works better than lomustine alone. **You may be eligible if...** - You are 18 or older with glioblastoma that has returned for the first time after standard treatment (surgery + radiation + temozolomide chemotherapy) - Your previous radiation ended at least 6 months ago - The tumor is measurable and no larger than 5 cm - You are in reasonably good health (WHO performance status 0–2) - You have not yet received any treatment for the recurrence (other than possibly surgery) **You may NOT be eligible if...** - You have received any prior cancer treatment for the recurrence (other than surgery) - You have had prior nitrosourea chemotherapy (like lomustine itself) - You have a known allergy to lomustine - You have significant blood count or kidney problems - You have active leukemia or a myeloid blood disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLomustine

Oral administration of Lomustine

RADIATIONReirradiation

Given at least 6 months after the end of prior radiotherapy

Locations(43)

A.O Landeskrankenhaus - Innsbruck Universitaetsklinik

Innsbruck, Austria

Kepler University Hospital - Neuromed campus

Linz, Austria

Universitaetsklinikum Wien - AKH unikliniken

Vienna, Austria

AZORG

Aalst, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Grand Hopital de Charleroi - Site Les Viviers

Gilly, Belgium

U.Z. Leuven - Campus Gasthuisberg

Leuven, Belgium

Masaryk Memorial Cancer Institute

Brno, Czechia

Aarhus University Hospitals - Region Midtjylland - Aarhus University Hospital-Skejby

Aarhus, Denmark

CHU d'Amiens - CHU Amiens Picardie - Site Sud

Amiens, France

CLCC - Jean Perrin

Clermont-Ferrand, France

CHRU de Lille

Lille, France

CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

Lyon, France

Institut du Cancer de Montpellier

Montpellier, France

CHU de Nice - Hôpital Pasteur

Nice, France

Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (233)

Paris, France

Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis

Paris, France

Institut de Cancerologie de l´Ouest (ICO) - Saint Herblain

Saint-Herblain, France

Univ. Knappschaft Krankenhaus Bochum

Bochum, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Erlangen-Schwabachanlage

Erlangen, Germany

Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

Heidelberg, Germany

Universitätsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie

Leipzig, Germany

Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern

Munich, Germany

Universitaetsklinikum Regensburg

Regensburg, Germany

Universitaetsklinikum Tuebingen- Crona Kliniken

Tübingen, Germany

IRCCS-Ospedale Bellaria-Bologna

Bologna, Italy

ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

Legnago, Italy

Istituto Clinico Humanitas

Milan, Italy

IRCCS - Istituto Oncologico Veneto

Padova, Italy

Azienda ospedaliero Univ Policlinico Umberto I

Roma, Italy

Medisch Spectrum Twente

Enschede, Netherlands

Leiden University Medical Centre

Leiden, Netherlands

Erasmus MC

Rotterdam, Netherlands

ETZ Tilburg - ETZ - St. Elisabethziekenhuis

Tilburg, Netherlands

Oslo University Hospital - Radiumhospitalet

Oslo, Norway

St Olavs University Hospital - St. Olavs Hospital, Trondheim University Hospital

Trondheim, Norway

Hospital Germans Trias i Pujol (Institut Catala D&#39;Oncologia)

Badalona, Barcelona, Spain

Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (381)

Badalona, Spain

ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

L'Hospitalet de Llobregat, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Oncology Institute of Southern Switzerland (IOSI) - Ospedale San Giovanni

Bellinzona, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05904119